BRAVO 3: New-onset AF after TAVR confers elevated risk for stroke

NEW ORLEANS — Patients with new-onset atrial fibrillation detected within 30 days after transfemoral transcatheter aortic valve replacement had a fourfold elevated risk for stroke, according to new data from the BRAVO 3 trial.

However, those with AF were not at elevated risk for other adverse events at 30 days compared with those without AF, Usman Baber, MD, MS, assistant professor of medicine at Icahn School of Medicine at Mount Sinai and a Cardiology Today Next Gen Innovator, said at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.

In the main BRAVO 3 study, 802 patients (mean age, 82 years) at high risk for surgery undergoing transfemoral TAVR were randomly assigned bivalirudin or unfractionated heparin; the groups did not differ in the primary endpoints of major bleeding and net adverse clinical events. In the present study, Baber and colleagues compared outcomes between the 332 patients who had AF at baseline or within 30 days of TAVR and the 470 patients who did not.

Usman Baber

At baseline, those with AF had a higher EuroSCORE (19 vs. 15.6; P < .0001), lower glomerular filtration rate (56.3 mL/min vs. 62.2 mL/min; P < .0001) and lower left ventricular ejection fraction (52.1% vs. 54.7%; P = .0021) compared with those with no AF, and during the procedure, those with AF were less likely to undergo postdilation (21.3% vs. 27.6%; P = .0417), Baber said.

All patients with AF had a CHA₂DS₂-VASc score of at least 2, and patients with AF were more likely to receive oral anticoagulation after TAVR than those without AF, he said.

“In the AF patients, 30% were discharged without any anticoagulation and just given dual antiplatelet therapy,” Baber said during a presentation. “About 65% did get some form of anticoagulation, the most common being aspirin with an anticoagulant, with about 22% getting a P2Y12 inhibitor with an anticoagulant, and 13% getting triple therapy. This demonstrates the heterogeneity and lack of a standard, uniform approach with respect to post-TAVR pharmacotherapy.”

At 30 days, there were no differences between patients with AF and patients without AF in Bleeding Academic Research Consortium (BARC) type 3b or greater bleeding, death, stroke, MACE, net adverse clinical events and major vascular complications, according to the researchers.

“For all of the outcomes, there were numerical differences indicating higher risk in those patients with [AF] compared to those without; nevertheless, none of these achieved statistical significance,” Baber said. In addition, outcomes by AF status did not significantly differ according to treatment with bivalirudin vs. heparin (P for interaction > .05 for all).

However, 10.5% of those with new-onset AF (n = 38) had stroke within 30 days of TAVR, compared with 3.1% of those with prior AF and 2.6% of those without AF (OR for new-onset AF vs. no AF = 4.49; 95% CI, 1.37-14.67), Baber said. “The mechanism for that association remains unclear,” he said.

“The numbers here are small … but nevertheless we see that for numerous endpoints, the new-onset AF patients did seem to fare worse compared to those who did not have [AF],” he said.

“The main thing I get out of this is that a lot of people [with AF] are not on anticoagulation when they go home, which seems like a very dangerous situation,” Spencer B. King III, MD, MACC, FSCAI, FESC, from the cardiology department at Emory Saint Joseph’s Hospital and Emory University School of Medicine and a member of the Cardiology Today Editorial Board, said during a panel discussion. – by Erik Swain

Reference:

Baber U, et al. Late-Breaking Clinical Trials I. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 10-13, 2017; New Orleans.

Disclosure: Baber reports no relevant financial disclosures.